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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04498923
Other study ID # LNMY-FPGE- ANESTHESIOLOGY-DBBA
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date April 5, 2022

Study information

Verified date April 2022
Source Lviv National Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The main aim of the investigator's study is to propose combination of local anesthetics and adjuvants that provides both adequate anesthesia during surgery and prolonged post-operative analgesia.


Description:

Peripheral nerve plexuses blocks are performing as a component of analgesia in patients undergoing orthopedic surgery on the upper or lower extremities. Patients are divided into two groups depending on the adjuvant to the local anesthetic: 1st group - patients whose blockade is performed with a solution of bupivacaine 0.375% together with dexamethasone 0.02%; Group 2 - patients whose blockade is performed with a solution of bupivacaine 0.375% together with dexamethasone 0.02% and epinephrine 0.00018%. The duration of the blockade is estimated by puncturing the skin with a needle. The intensity of pain is assessed at 6, 12, 24 and 36 hours after blockade using Visual analog scale (VAS). The amount of narcotic anesthetic used in the postoperative period is also recorded. In addition, patients underwent electromyography of the innervation area of the blocked nerve before the surgery and 24 and 36 hours after surgery.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date April 5, 2022
Est. primary completion date April 5, 2022
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria: - All patients undergoing upper or lower extremity orthopedic surgery Exclusion Criteria: - diabetes mellitus; - diseases of the peripheral nerv system

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Bupivacaine, dexamethasone, epinephrine
Bupivacaine 75 mg, dexamethasone 4 mg, epinephrine 0,18 mg

Locations

Country Name City State
Ukraine Rivne Oblast State Hospital Rivne Rivne Region

Sponsors (1)

Lead Sponsor Collaborator
Lviv National Medical University

Country where clinical trial is conducted

Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary The duration of blockade The duration of the blockade was estimated by puncturing the skin with a needle every hour. In addition, patients underwent electromyography of the innervation area of the blocked nerve before the surgery and 24 and 36 hours after surgery. 6th, 12th, 24th and 36th hours after blockade
Secondary The amount of narcotic anesthetic used in the postoperative period 48 hour after surgery
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